Efficacy and safety of pantoprazole versus ranitidine in the treatment of patients with symptomatic gastroesophageal reflux disease
Date
2004
Authors
Van Zyl J.
Van Rensburg C.
Vieweg W.
Fischer R.
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Abstract
Background/Aim: Gastroesophageal reflux disease (GERD) is a prevalent disease associated with a high symptom burden and a reduced quality of life. This multicenter, randomized, double-blind study compared relief from key GERD symptoms (heartburn, acid eructation, and pain on swallowing) and from other gastrointestinal symptoms (epigastric pain, vomiting, nausea, flatulence, retching, and retrosternal feeling of tightness) and safety profiles of the proton pump inhibitor pantoprazole and the H2 antagonist ranitidine in patients suffering from symptomatic GERD. Methods: The patients [338 intention-to-treat (ITT) population; 284 per-protocol (PP) population] received 20 mg pantoprazole (once daily in the morning) plus ranitidine placebo (once daily in the evening; ITT n = 167, PP n = 136) or pantoprazole placebo (once daily in the morning) plus 300 mg ranitidine (once daily in the evening; ITT n = 171, PP n = 148) for 28 days. The primary efficacy criterion (ITT and PP populations) was relief from key GERD symptoms (heartburn, acid eructation, and pain on swallowing) after 28 days of treatment. Secondary criteria (PP) included relief from key GERD symptoms on day 14, relief from all gastrointestinal symptoms on days 14 and 28, and relief from key GERD symptoms on days 14 and 28. Safety evaluations included adverse events and laboratory assessments. Results: Significantly more pantoprazole-treated patients were free from key GERD symptoms at day 28 (68.3%, n = 114) as compared with ranitidine-treated patients (43.3%, n = 74; 95% confidence interval for odds ratio 1.84-4.51). Pantoprazole was also significantly more efficacious in controlling all gastrointestinal symptoms of GERD. By day 28, 51.5% (n = 70) of the pantoprazole-treated patients were completely symptom free versus 31.1% (n = 46) of the ranitidine-treated patients (95% confidence interval for odds ratio1.45-3.83). Both treatments were well tolerated. Conclusion: Pantoprazole is significantly superior to ranitidine in the treatment of key and associated gastrointestinal symptoms of GERD and is well tolerated. Copyright © 2004 S. Karger AG, Basel.
Description
Keywords
acetylsalicylic acid, atenolol, conjugated estrogen, dipeptidyl carboxypeptidase inhibitor, histamine H2 receptor antagonist, hydrochlorothiazide, pantoprazole, perindopril, proton pump inhibitor, ranitidine, theophylline, abdominal pain, adult, aged, article, clinical trial, confidence interval, constipation, controlled clinical trial, controlled study, diarrhea, double blind procedure, drug efficacy, drug safety, dysphagia, epigastric pain, eructation, female, flatulence, gastroesophageal reflux, gastrointestinal symptom, heartburn, human, major clinical study, male, multicenter study, nausea, pain, phase 3 clinical trial, priority journal, pruritus, randomized controlled trial, urticaria, vertigo, vomiting, 2-Pyridinylmethylsulfinylbenzimidazoles, Administration, Oral, Adult, Aged, Anti-Ulcer Agents, Benzimidazoles, Double-Blind Method, Female, Gastroesophageal Reflux, Humans, Male, Middle Aged, Odds Ratio, Omeprazole, Placebos, Ranitidine, Severity of Illness Index, Sulfoxides, Treatment Outcome
Citation
Digestion
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